09 February 2010

NAS on COI

The New York Times has an article today about the issue of conflicts of interest and Dr. Rajendra Pachauri, head of the IPCC. I thought that it might be worth sharing what the U.S. National Academy of Sciences says about conflicts of interest, as an example of how one leading scientific advisory body sees the issue as related to advice related to government regulation (full document here in PDF). If the IPCC decided today to adopt the NAS guidelines, would Dr. Pachauri be judged to have conflict(s) of interest? I think that the answer is pretty obvious.

It is essential that the work of committees of the institution used in the development of reports not be compromised by any significant conflict of interest. For this purpose, the term "conflict of interest" means any financial or other interest which conflicts with the service of the individual because it (1) could significantly impair the individual's objectivity or (2) could create an unfair competitive advantage for any person or organization. Except for those situations in which the institution determines that a conflict of interest is unavoidable and promptly and publicly discloses the conflict of interest, no individual can be appointed to serve (or continue to serve) on a committee of the institution used in the development of reports if the individual has a conflict of interest that is relevant to the functions to be performed.

The term "conflict of interest" means something more than individual bias. There must be an interest, ordinarily financial, that could be directly affected by the work of the committee.

Conflict of interest requirements are objective and prophylactic. They are not an assessment of one's actual behavior or character, one's ability to act objectively despite the conflicting interest, or one's relative insensitivity to particular dollar amounts of specific assets because of one's personal wealth. Conflict of interest requirements are objective standards designed to eliminate certain specific, potentially compromising situations from arising, and thereby to protect the individual, the other members of the committee, the institution, and the public interest. The individual, the committee, and the institution should not be placed in a situation where others could reasonably question, and perhaps discount or dismiss, the work of the committee simply because of the existence of conflicting interests.

The term "conflict of interest" applies only to current interests. It does not apply to past interests that have expired, no longer exist, and cannot reasonably affect current behavior. Nor does it apply to possible interests that may arise in the future but do not currently exist, because such future interests are inherently speculative and uncertain. For example, a pending formal or informal application for a particular job is a current interest, but the mere possibility that one might apply for such a job in the future is not a current interest.

The term "conflict of interest" applies not only to the personal interests of the individual but also to the interests of others with whom the individual has substantial common financial interests if these interests are relevant to the functions to be performed. Thus, in assessing an individual's potential conflicts of interest, consideration must be given not only to the interests of the individual but also to the interests of the individual's spouse and minor children, the individual's employer, the individual's business partners, and others with whom the individual has substantial common financial interests. Consideration must also be given to the interests of those for whom one is acting in a fiduciary or similar capacity (e.g., being an officer or director of a corporation, whether profit or nonprofit, or serving as a trustee).

This disclosure form is used for any committee that will be used by the institution in the development of one or more reports to be provided by the institution to a sponsoring agency for use in a government regulatory process. For such projects, the focus of the conflict of interest inquiry is on the identification and assessment of any interests that may be directly affected by the use of such reports in the regulatory process.

For example, if this institution were conducting a study of proposed modifications in the government regulation of a particular application of biotechnology, the focus of the conflict of interest inquiry would be on the identification and assessment of any interests that would be directly affected by that regulatory process if the institution's report were to provide the basis for regulatory action or inaction. The concern is that if an individual (or others with whom the individual has substantial common financial interests) has specific interests that could be directly affected by the regulatory process, the individual's objectivity could be impaired.

Such interests could include an individual's stock holdings in excess of $10,000 in a potentially affected biotechnology company or being an officer, director, or employee of the company. Serving as a consultant to the company could constitute such an interest if the consulting relationship with the company could be directly affected or is directly related to the subject matter of the regulatory process.

An individual's other possible interests might include, for example, relevant patents and other forms of intellectual property, serving as an expert witness in litigation directly related to the subject matter of the regulatory process, or receiving research funding from a party that would be directly affected by the regulatory process if the research funding could be directly affected or is directly related to the subject matter of the regulatory process and the right to independently conduct and publish the results of this research is limited by the sponsor. Consideration would also need to be given to the interests of others with whom the individual has substantial common financial interests -- particularly spouses, employers, clients, and business or research partners.